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Otezla Letter of Medical Necessity with Step-By-Step Directions | Otezla® (apremilast) Healthcare Professional Site
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3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. Read less

Read less

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA

SEE THE DATA REFERENCES

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1 START TODAY WITHOUT DELAY

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1

START TODAY WITHOUT DELAY REFERENCES

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,* PLAQUE PSORIASIS SAFETY PsA SAFETY

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,*

PLAQUE PSORIASIS SAFETY PsA SAFETY REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=58% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.

FDA, U.S. Food and Drug Administration; PsA, psoriatic arthritis; TB, tuberculosis.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Otezla® (apremilast) FDA approval letter. March 21, 2014.

OTEZLA® (APREMILAST) LETTER OF MEDICAL NECESSITY

Please use these links to access the Otezla Letter of Medical Necessity (LoMN)

To receive by fax, or if you have any questions, call 1-844-4OTEZLA (1-844-468-3952)

Thumbnail image of 3 pages for the Otezla Letter of Medical Necessity
  • This document is provided for use by healthcare professionals
  • The Otezla Letter of Medical Necessity is provided to assist with appealing a coverage denial for an Otezla prescription
  • What happens if the Otezla Letter of Medical Necessity has been denied? If a coverage appeal is still denied, refer the patient to Amgen® SupportPlus Representatives to determine eligibility for the Patient Support Program
  • Call us with questions toll free 8 AM – 8 PM ET, Monday – Friday

PREVIEW DOWNLOADABLE LoMN

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COMPOSING A LETTER OF MEDICAL NECESSITY

Preview content in downloadable below

This guide is for informational purposes only. It is not intended to provide reimbursement or legal advice. Individual health plans’ policies concerning reimbursement are complex and frequently revised. Therefore, please contact third-party payers for specific information on coverage policies. For more information, please call 1-844-4OTEZLA (1-844-468-3952).

Many plans require a Letter of Medical Necessity to accompany an Appeal Letter supporting the choice of Otezla® (apremilast) over other agents that are on the formulary. The purpose of the letter is to explain the rationale for the drug.* The following resource provides information to help in the process of writing a Letter of Medical Necessity, including the checklist below and a sample letter.

CHECKLIST

This checklist can help ensure all relevant information is included in the Letter of Medical Necessity:

 

Patient’s name, policy number, and date of birth

 

Support for recommending Otezla (patient history, diagnosis, and current condition; include relevant medical records and history of infections, allergies, and existing comorbidities)

 

Documentation of severity of condition (include photos)

 

List of previous therapies and duration of treatment, including explanation of why each therapy was discontinued

 

Explanation of why formulary-preferred agents are not appropriate and clinical support for your recommendation (this clinical trial data can be from the Otezla package insert)

*For Medicare beneficiaries, there are specific requirements that need to be met for the HCP to be considered a legal representative of the patient in an appeal. For additional information, please visit: https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/Downloads/Parts-C-and-D-Enrollee-Grievances-Organization-Coverage-Determinations-and-Appeals-Guidance.pdf.

 

SAMPLE LETTER OF MEDICAL NECESSITY

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Step 1.

Step 2.

Step 3.

Step 1.

Include the patient information

Step 2.

Provide the information relevant to the
primary diagnosis

Step 3.

Describe the patient history and current condition (include copies of relevant medical records)

Thumbnail of Otezla Letter of Medical Necessity page 2 of 2

Step 4.

Step 5.

Step 6.

Step 7.

Step 8.

Step 9.

Step 4.

Outline the severity of symptoms (include pictures, as appropriate)

Step 5.

List previous therapies

Step 6.

Include patient’s clinical response to prior therapy

Step 7.

Include your recommendation here. Include clinical rationale and your professional opinion of the patient’s likely prognosis or disease

Step 8.

Provide a phone number should any additional information be required

Step 9.

Please sign your name to complete the letter

PLEASE BE SURE THAT ALL RELEVANT SECTIONS OF THE LETTER
ARE COMPLETELY AND CORRECTLY FILLED OUT

OTEZLA LETTER OF MEDICAL NECESSITY

Medical director
Insurance company
Address line 1
Address line 2
Address line 3
Address line 4
Patient name
Policy number
Date of birth

PHYSICIAN’S REQUEST FOR REVIEW:

 

Peer-to-peer review requested (same or like specialty)

 

Other

 
 

Dear

 

I am writing to provide additional information to support my request for the treatment of

 

with Otezla® (apremilast) for Primary

 

L40.50 (Arthropathic psoriasis,
unspecified)

 

L40.51 (Distal interphalangeal
psoriatic arthropathy)

 

L40.52 (Psoriatic arthritis mutilans)

 

L40.53 (Psoriatic spondylitis)

 

L40.59 (Other psoriatic arthropathy)

 

L40.0
(Psoriasis vulgaris)

%BSA Affected
 

L40.8
(Other psoriasis)

%BSA Affected
 

L40.9
(Psoriasis, unspecified)

%BSA Affected
 

M35.2
(Behçet’s Disease)

In brief, treating

 

with Otezla is medically appropriate and necessary and should be covered and reimbursed. Below, this letter outlines the medical history, prognosis, and treatment rationale for

 
 

SUMMARY OF PATIENT HISTORY:

[Note: Exercise your medical judgment and discretion when providing a diagnosis and characterization of the patient’s medical condition.]

Patient’s history, diagnosis, and current condition:

 

Brief description of the patient’s recent symptoms and conditions (including BSA% for Plaque Psoriasis patients):

 

Previous therapies the patient has undergone for the symptoms associated with:

 

Patient’s response to previous therapies. If patient has discontinued, please include reason for discontinuation:

 

Summary of your professional opinion and the patient’s potential prognosis with treatment with Otezla® (apremilast):

 

Please call my office at

 

if I can provide you with any additional information to approve my request. I look forward to receiving your timely response and approval of this request.

 

Sincerely,

 
 

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IMPORTANT SAFETY INFORMATION 

Contraindications

Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation 

Warnings and Precautions

Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider
    discontinuation of Otezla
    • Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of
      patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis
  • Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
  • Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Use in Specific Populations

  • Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss

Please click here for the full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for
phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.